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MOU number: 225-74-6004

Memorandum of Understanding

Between
The Department of the Treasury
United States Customs Service

and

The Food and Drug Administration

The United States Customs Service of the Department of the Treasury (hereinafter referred to as USCS) and the Food and Drug Administration (hereinafter referred to as FDA) do hereby jointly agree to the following terms and conditions as stated herein.

Purpose: To identify the authority and roles for cooperative efforts between two agencies regarding the entry and clearance operation, the determination of compliance status, and the sampling procedures of imported electronic products subject to the Radiation Control for Health and Safety Act (42 USC 263b through n) of 1968.

I. Statutes and Regulations

The Food and Drug Administration is charged with the administration and enforcement of the Radiation Control for Health and Safety Act of 1968. The FDA evaluates reports of manufacturer's testing and quality control programs, inspects facilities, and samples imported electronic products for the purpose of determining how the manufacturer's procedures assures that imported electronic products will be in compliance with the standards prescribed under Section 358 of the Public Health Service Act as amended (42 USC 263f). That Act provides that manufacturers of electronic products must certify that these products comply with applicable performance standards.

The U.S. Customs Service is charged with assuring that imported electronic products subject to standards in effect under Section 358 of the Act, shall be refused entry unless these products comply with the standards and are so certified. When samples of these products are requested by FDA, the District Director of Customs having jurisdiction over the shipment from which the sample is procured, shall give its owner or consignee prompt notice of the delivery or intention to deliver such samples. If required, the owner or consignee shall hold the shipment of which the sample is typical and not release such shipment until a notice of the test results from FDA states that the product is in compliance. Noncomplying products whose importers or consignees declare they will petition FDA for permission to bring the product into compliance shall be accepted for entry only if the importer or consignee gives a bond for the production of an FDA notification that the product has been brought into conformity with the applicable standard.

Noncomplying electronic products whose importer or consignee declares the products are imported for test and evaluation or are for use in obtaining orders, shall be accepted for entry only if the FDA exempts them from certification, and the importer or consignee assures they will control these products, not introduce them into commerce, and that when the need for these products is completed, they will be destroyed or exported under Custom's supervision.

II. Services to be Performed

A. Certain functions now effected by the U.S. Customs Service will be done under the auspices of the Deputy Regional Food and Drug Director (DRFDD) who will:

1. Advise Customs and importers/brokers as to shipments of imported electronic products subject to the Act and which require declarations.

2. Accept declarations and notification from USCS in accord with existing local procedures being used on the importation of other products subject to food and drug inspection. Make a determination of the legality of the shipments relative to the Act.

3. Review the declaration and notify the importer/broker and Customs, in writing, of the action to be taken. This will include:

a. Rejection of the declaration when incomplete or inaccurate, and return it to the importer/broker for correction and resubmission. USCS to be notified of FDA action by copy of correspondence.

b. Acceptance of the declaration when complete and correct which affirms that the products were made prior to the effective date of the applicable standard and notification of authorization relative to the Act to USCS to release the shipment.

c. Acceptance of the declaration when complete and correct on certified products and notification of authorization relative to the Act to Customs to release the shipment.

d. Acceptance of the declaration when complete and correct which affirms that all products offered for import are for test and evaluation or for taking.

Notification to importer/broker and to Customs that products can be delivered to importers or consignees to remain in their control and not to be sold pending acceptance by FDA of requests for exemption from certification from importer.

Notification to importers and USCS that FDA has granted the exemption and that the products are to be destroyed or exported under USCS's supervision when the need for the product is completed.

Notification to importers and USCS of FDA disapproval of requests for exemption.

e. Acceptance of the declaration which affirms that the non-complying products offered for import are to be brought into compliance.

Notification to USCS that an appropriate bond is to be posted by the importer or consignee. This bond to remain in effect until approval of the rework program and statement from FDA to Customs that the products are in compliance with the applicable Federal performance standard. The importer will not transfer the products from the delivery point nor allow them to be sold.

Notification to USCS to release the products from bond when the products are brought into compliance.

Notification to USCS of action to be taken when the importer has failed to bring the product into compliance.

4. Obtain samples of imported electronic products The identification of the sample will be made by FDA which will also designate where sampling is to be accomplished. Collection of samples will be conducted by the DRFDD who will follow existing local procedures. Samples will be obtained within the time frame of Customs control of the products. DRFDD will advise USCS on the disposition of the shipment from which the samples were obtained.

B. The U.S. Customs Service will:

1. Accept notice from FDA of the shipments subject to the Act and require submission of declarations from importers/brokers.

2. Notify and deliver declarations to FDA in accord with existing local procedures being used on the importation of other products subject to food and drug inspections.

3. Accept written notification from FDA of the actions which are to be taken regarding these shipments relative to the Act and take appropriate action including the following:

a. Accept written notice of rejection by FDA of incorrect declarations which have been returned to importers/brokers and subsequent action to be taken.

b. Accept written notice that FDA has reviewed the declaration affirming the products were made prior to the effective date of the applicable standard and has found it to be complete and correct. Release the shipment.

c. Accept written notice that FDA has reviewed the declaration affirming the products are in compliance and has found it to be complete and correct. Release the shipment.

d. Accept notification that FDA has reviewed the declaration affirming that the noncomplying products are imported for test and evaluation or order taking purposes. Authorize delivery of the products to the importer or consignee. Require products to remain in the importer's control. Accept notification that FDA has granted an exemption from certification for these products.

Supervise export or destruction of products when the need for the products is completed or when FDA disapproval of request for exemption is received.

e. Accept notification that FDA has reviewed the declaration affirming that noncomplying products are being imported and that the importer intends to bring them into compliance. Authorize delivery of the products to the importer after the appropriate bond has been filed. The importer will not transfer the products from the delivery point nor allow them to be sold.

Accept notification from FDA and release the products from bond when the products are brought into compliance.

Accept notification from FDA of action to be taken when the importer has failed to bring the product into compliance.

4. Upon request FDA, USCS will notify importers to provide FDA with samples selected by FDA and authorize FDA to collect such samples.

III. Name and Address of Participating Agency

U.S. Customs Service
Department of the Treasury
Washington, D.C. 20229

IV. Liaison Officers

A. Chief, Compliance Branch
Duty Assessment Division
Office of Operations
U.S. Customs Service
2100 K Street, NW.
Washington, D.C. 20229
Telephone: (202) 964-8651

B. Chief, Compliance Operations Branch
Division of Compliance, HFX-480
Bureau of Radiological Health
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20852
Telephone: (301) 443-3516

V. Period of Agreement

This agreement, when accepted by both parties, covers an indefinite period of time and may be modified by mutual consent of both parties or terminated by either party upon a thirty (30) day advance written notice to the other.

Nothing in this agreement modifies previously existing agreements nor does it preclude entering into separate agreements setting forth procedures for special programs which can be handled more efficiently and expeditiously by such special agreement.

VI. Authority

This agreement is entered into under the authority of the Economy Act, approved June 30, 1932, as amended, 31 USC 686.

Domestic MOUs

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